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Re: exwannabe post# 71184

Thursday, 08/25/2016 1:48:40 PM

Thursday, August 25, 2016 1:48:40 PM

Post# of 817868
Results will be coming soon and as tastygreenwafers points out on investor village, they do not have to wait for PFS or OS to end the trial. Meeting the following criteria they will qualify for accelerated approval and as the UK NHS reported in april 06th that is exactly what NWBO was doing

"Apr 16: Northwest Bio plans to apply for fast track status in the US [18].
16/06/2016 09:41:53"


"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval."

http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4815


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